Epimed International recalls RX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)TW, 10 units, Calibrated, Plastic Hub, Detachable Wing, Blunt Stylet, St…

Recall date

July 24, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0087-2018

FDA classification

Class II

Brand / firm

Epimed International

Sold / distributed

Domestic: AR, CA, IA, IN, KY, LA, MI, NY, OH, OR, TN, TX, & WA. Foreign: Canada, Czech Republic, Germany ,& Turkey.

Why it was recalled

Potential for partially incomplete seal of product, impacting sterility.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

RX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)TW, 10 units, Calibrated, Plastic Hub, Detachable Wing, Blunt Stylet, Sterile, Rx only, For Use with 19g or Smaller Catheter